Wednesday, November 19, 2014

Solgar Inc. Recalls Dietary Supplement

The product, ABC Dophilus Powder, was found to contain the fungus rhizopus oryzae, which is linked to the infection mucormycosis. The federal Centers for Disease Control tested the powder after the October death of a preterm infant who had been given ABC Dophilus in a hospital. The baby, who had been born at 29 weeks, suffered from multiple complications, including intestinal mucormycosis, according to Solgar.

Andrea Staub, a spokeswoman for Solgar, said  that the company and the Food and Drug Administration are still investigating whether there was any connection between the product and the baby's death. She declined to give the name or location of the hospital where the death occurred.

The company initiated the recall "out of an abundance of caution," Staub said.
She said the recall involves fewer than 2,000 bottles, which were made by a subcontractor she declined to identify.

Rhizopus oryzae is found in soil and can cause mucormycosis, especially in people with diabetes, cancer, skin trauma or compromised immune systems. Otherwise healthy people can also catch the infection, though rarely, according to the FDA.
ABC Dophilus Powder is a supplement for infants and children containing "friendly" bacteria to aid in digestive health.

Friday, November 07, 2014

AMP Citrate Ingredient Causes Concerns

From USA Today:

News reports are mentioning AMP citrate, which some consider to be a close cousin of DMAA. AMP citrate is sometimes referred to as methylpentanamine.  Scientists in the United States and the Netherlands testing several products found that the amount of the new synthetic stimulant varies widely, the dosage isn't disclosed on labels, there isn't much evidence that the chemical is natural and none that it's safe in humans. 

Read more here:

Supplements safe after FDA recall? Don't count on it

This article from the Los Angeles Times is worth a read:

 Several months after supplements were recalled for being illegally laced with prescription drugs, researchers bought them off the shelves and from the online inventories of supplement retailers and checked whether they continued to contain the illegal substances for which they'd been recalled.In two-thirds of cases, the supplements did. 

Link here:

FDA Finally Takes Bab Steps on Supplement Weight Loss Claims

I'm not a fan of the woefully understaffed, underfunded FDA. In spite of the business sector's overwhelming fiscal might, there are signs of hope. This story is one sign.  

The Food and Drug Administration is moving forward with new proposals to the manufacturers of dietary supplements that have drawn a closer look because of claims of  miracle weight loss.
The FDA already prohibits pharmaceutical companies from making misleading claims about their dietary supplements. To help manufacturers comply with these rules, the agency has issued voluntary guidelines for companies making dietary supplement claims.
The guidelines show what evidence companies will need to back up their dietary supplement's "general well-being claims." This could include articles published in peer-reviewed scientific journals, for example.
"It is unlikely that a dietary supplement manufacturer will attempt to make a claim when the cost of obtaining the evidence to support the claim outweighs the benefits of having the claim on the product’s label," the FDA wrote in the Federal Register.
Find this report:   Agency Information Collection Activities; Proposed Collection; Comment Request; 
Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and 
Cosmetic Act here